FIMEA
Competent authority · Finland · Helsinki
A national competent authority for medical devices under the EU MDR/IVDR — market surveillance, vigilance and EUDAMED registration oversight.
A national body that oversees the application of EU medical-device regulation in its country — market surveillance, vigilance, economic-operator validation and EUDAMED registration oversight, under MDR Articles 101–108.
Explore every authority and economic operator registered in Finland.
A national body that oversees the application of EU medical-device regulation in its country — surveillance, vigilance, and registration oversight.
No — that's a notified body. A competent authority supervises the market; it does not issue device certificates.
Sourced directly from EUDAMED. This record was last updated Jun 25, 2026.
Operators whose registration was validated by this authority.
| Operator | Role | SRN | Country |
|---|---|---|---|
| 2M-IT Oy | Manufacturer | FI-MF-000013044 | FI |
| 3Dent Oy | Importer | FI-IM-000046561 | FI |
| 4B World Technology CO., LTD. | Manufacturer | CN-MF-000025830 | CN |
| 4N Health Oy Ltd | Manufacturer | FI-MF-000004502 | FI |
| 6D Tape Inc. | Manufacturer | FI-MF-000006933 | FI |
| 73Health Oy | System / procedure pack producer | FI-PR-000042130 | FI |